Trial reportClinical pharmacology in drug development2026
Pharmacokinetic Comparison Between a Fixed-Dose Combination of Atorvastatin/Fenofibrate 20/145 mg and the Corresponding Individual Components.
Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
Co-administration of atorvastatin and fenofibrate has demonstrated clinical benefits in patients with dyslipidemia. To improve convenience and adherence, a fixed-dose combination (FDC) of the two agents has gained interest. This study aimed to compare the pharmacokinetics (PKs) and safety of an FDC of atorvastatin/fenofibrate 20/145 mg with the corresponding individual components. A randomized, open-label, single-dose, two-sequence, two-treatment, four-period full replicated crossover study was conducted. Participants were randomly assigned to one of the two sequences and received FDC or individual components. PK parameters were estimated using a non-compartmental method. The geometric mean ratio (GMR) and its 90% confidence interval (CI) of the FDC to the individual components were calculated using mixed effect model. A total of 36 participants completed the study. The GMRs (90% CIs) for maximum plasma concentration and area under the time-concentration curve from zero to the last measurable point were 1.1038 (0.9985-1.2202) and 1.0148 (0.9745-1.0567) for atorvastatin, 1.0032 (0.9261-1.0867) and 0.9882 (0.9520-1.0258) for 2-OH atorvastatin. For fenofibric acid, the corresponding values were 0.9896 (0.8810-1.1116) and 0.9871 (0.8869-1.0986), respectively. The FDC of atorvastatin/fenofibrate 20/145 mg showed comparable PK profiles to the corresponding individual components, supporting its potential as an alternative therapeutic option for dyslipidemia with convenience.
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